Repeated IVF FailurePhase 2Thrive-IVFNCT01864356
A Multi-Center Study To Evaluate Multiple Doses of NT100 Following IVF In Women With Repeated IVF Failures (Thrive-IVF)
A Phase 2 study testing NT100 in people with Repeated IVF Failure, run by Nora Therapeutics, Inc. at 21 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of subcutaneous NT100 vs placebo following in vitro fertilization (IVF) in women with a history of repeated IVF failures. Read more about this study
- Who is it for?
- Ages 21 to 38 years, women only
- Conditions the study is for
- Repeated IVF Failure
- What is being tested?
- NT100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 21 sitesUnited States
- Study dates
- May 2013to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pre-menopausal female 21-38 years of age at screening
- History of repeated IVF failures despite transfer of good-quality embryos, defined as follows:
- ...1) 3 or more IVF cycles involving transfer of at least two good-quality cleavage-stage embryos or at least one good-quality blastocyst (2010 SART (Society for Assisted Reproductive Technologies) grading criteria)that resulted in one of the following outcomes:
- * .....a) no pregnancy
- * .....b) biochemical pregnancy
- * .....c) spontaneous abortion of an intrauterine clinical pregnancy before or equal to completed Week 8 of gestation
Show all 11Show fewer
- ...2) At least two of the eligible IVF failures must have involved transfer of fresh embryos
- ...3) At least two of the eligible IVF failures must have involved retrieval of at least 5 oocytes
- ...4) No live birth, abortion later than Week 8 of gestation, or stillbirth may have occurred since the first of these IVF failures
- Body mass index (BMI) of 19-38 kg per m2 at screening
- TSH (thyroid-stimulating hormone) less than or equal to 4.0 mIU/L(milli-International units per Liter) for subjects with no history of hypothyroidism, or TSH less than or equal to 2.5 mIU/L for subjects with a history of hypothyroidism, at screening
Who cannot join
- Prior diagnosis of moderate or severe ovarian hyperstimulation syndrome (OHSS)
- Clinically confirmed polycystic ovary syndrome (PCOS)
- History of a major congenital anomaly in the subject, her current male partner, or first degree relative of either the subject or her current male partner
- Known karyotype abnormalities in either the subject or her current male partner / sperm donor
- Any prior pregnancy terminated for a fetal medical condition
- History of severe (stage IV) endometriosis
- Current or past systemic autoimmune disease
- Any uncontrolled clinically significant medical condition (e.g. asthma, Type II diabetes, infection)
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Georgia Reproductive Specialists
Atlanta, Georgia, 30342
Center for Assisted Reproduction
Bedford, Texas, 76022
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Main Line Fertility Center
Bryn Mawr, Pennsylvania, 19010
Fertility Centers of Illinois / River North IVF Center
Chicago, Illinois, 60610
Institute for Reproductive Health
Cincinnati, Ohio, 45209
Florida Fertility Institute
Clearwater, Florida, 33759
HRC Fertility
Encino, California, 91436
Fertility Centers of Illinois / Highland Park IVF Center
Highland Park, Illinois, 60035
Houston Fertility Institute
Houston, Texas, 77063
IVF and Fertility Center of Miami
Miami, Florida, 33176
Columbia University
New York, New York, 10032
Reproductive Associates of Delaware
Newark, Delaware, 19713
HRC Fertility
Newport Beach, California, 92663
HRC Fertility
Pasadena, California, 91105
Utah Fertility Center
Pleasant Grove, Utah, 84062
Shady Grove Fertility
Rockville, Maryland, 20850
UCSF
San Francisco, California
Boston IVF
Waltham, Massachusetts
Columbia Fertility Associates
Washington D.C., District of Columbia, 20037
Center of Reproductive Medicine
Webster, Texas, 77598
About this study
Official title: A Randomized, Double Blind, Multi-Center, Placebo Controlled Study To Evaluate The Efficacy, Safety, And Tolerability Of Multiple Doses Of NT100 Following IVF In Women With A History Of Repeated IVF Failures (Thrive-IVF)
The purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of subcutaneous NT100 vs placebo following in vitro fertilization (IVF) in women with a history of repeated IVF failures.
Read the detailed description
NT-03 will be a randomized, double blind, multi-center, placebo controlled study of multiple doses of subcutaneous NT100 following IVF in women with a history of repeated IVF failures. Approximately 150 subjects will be randomized in a 1:1:1 ratio to receive subcutaneous NT100 low dose, NT100 high dose, or placebo, qd for up to 4 weeks.
Screening will include a standard IVF stimulation protocol, followed by fertilization and culture of embryos. If the subject remains eligible, she will be randomized to receive study drug. All subjects will be followed for 4 weeks after the last dose of study drug. At Week 10 of gestation, subjects who are pregnant will roll over into a follow-up study (NT-04) to assess subsequent pregnancy, delivery, and neonatal outcomes.
- Conditions
- Repeated IVF Failure
- Being tested
- NT100, Placebo
- Keywords
- IVF failure, Repeated IVF failure, Implantation failure, Repeated implantation failure, IVF, NT100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT100Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| NT100 Dose 1 | Experimental | NT100 Dose 1 Receives: Drug: NT100 |
| NT100 Dose 2 | Experimental | NT100 Dose 2 Receives: Drug: NT100 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing clinical pregnancy rate
The primary efficacy outcome measure is the ongoing clinical pregnancy rate at Week 8 of gestation.
Measured: Week 8 of gestation
Secondary outcomes (6)
Biochemical evidence of pregnancy rate (as measured by hCG)
Measured: Week 4 of gestation
Ongoing clinical pregnancy rate
Measured: Weeks 6 and 10 of gestation
Implantation rate following embryo transfer
Measured: Week 8 of gestation
Number of subjects with adverse events and serious adverse events
Measured: through 4 weeks after last dose of study drug (up to Week 10 of gestation)
Changes in clinical laboratory parameters following study drug exposure
Measured: through 4 weeks after the last dose of study drug (up to Week 10 of gestation)
Moderate to severe ovarian hyperstimulation syndrome (OHSS) rate
Measured: through Week 10 of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repeated IVF FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nora Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864356
- Sponsor's protocol ID
- NT-03
- Acronym
- Thrive-IVF
- Status last verified
- Nov 2014
- First submitted
- 14 May 2013
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Multi-Center, Placebo Controlled Study To Evaluate The Efficacy, Safety, And Tolerability Of Multiple Doses Of NT100 Following IVF In Women With A History Of Repeated IVF Failures (Thrive-IVF)
- ClinicalTrials.gov ID
- NCT01864356
- Acronym / sponsor ID
- Thrive-IVF / NT-03
- Conditions
- Repeated IVF Failure
- Keywords
- IVF failure, Repeated IVF failure, Implantation failure, Repeated implantation failure, IVF, NT100
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Nora Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of subcutaneous NT100 vs placebo following in vitro fertilization (IVF) in women with a history of repeated IVF failures.
Detailed description
NT-03 will be a randomized, double blind, multi-center, placebo controlled study of multiple doses of subcutaneous NT100 following IVF in women with a history of repeated IVF failures. Approximately 150 subjects will be randomized in a 1:1:1 ratio to receive subcutaneous NT100 low dose, NT100 high dose, or placebo, qd for up to 4 weeks.
Screening will include a standard IVF stimulation protocol, followed by fertilization and culture of embryos. If the subject remains eligible, she will be randomized to receive study drug. All subjects will be followed for 4 weeks after the last dose of study drug. At Week 10 of gestation, subjects who are pregnant will roll over into a follow-up study (NT-04) to assess subsequent pregnancy, delivery, and neonatal outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NT100 Dose 1 | Experimental | Drug: NT100NT100 Dose 1 |
| NT100 Dose 2 | Experimental | Drug: NT100NT100 Dose 2 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 21 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Pre-menopausal female 21-38 years of age at screening
- History of repeated IVF failures despite transfer of good-quality embryos, defined as follows:
- ...1) 3 or more IVF cycles involving transfer of at least two good-quality cleavage-stage embryos or at least one good-quality blastocyst (2010 SART (Society for Assisted Reproductive Technologies) grading criteria)that resulted in one of the following outcomes:
- * .....a) no pregnancy
- * .....b) biochemical pregnancy
Key exclusion criteria (8 listed)
- Prior diagnosis of moderate or severe ovarian hyperstimulation syndrome (OHSS)
- Clinically confirmed polycystic ovary syndrome (PCOS)
- History of a major congenital anomaly in the subject, her current male partner, or first degree relative of either the subject or her current male partner
- Known karyotype abnormalities in either the subject or her current male partner / sperm donor
- Any prior pregnancy terminated for a fetal medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT100 | Drug | NT100 Dose 1, NT100 Dose 2 |
| Placebo | Drug | Placebo |
Primary outcome
Ongoing clinical pregnancy rate
Time frame: Week 8 of gestation
The primary efficacy outcome measure is the ongoing clinical pregnancy rate at Week 8 of gestation.
6 secondary outcomes
Biochemical evidence of pregnancy rate (as measured by hCG)
Time frame: Week 4 of gestation
Ongoing clinical pregnancy rate
Time frame: Weeks 6 and 10 of gestation
Implantation rate following embryo transfer
Time frame: Week 8 of gestation
Number of subjects with adverse events and serious adverse events
Time frame: through 4 weeks after last dose of study drug (up to Week 10 of gestation)
Changes in clinical laboratory parameters following study drug exposure
Time frame: through 4 weeks after the last dose of study drug (up to Week 10 of gestation)
Moderate to severe ovarian hyperstimulation syndrome (OHSS) rate
Time frame: through Week 10 of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NT100 in people with Repeated IVF Failure, run by Nora Therapeutics, Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing clinical pregnancy rate (time frame: Week 8 of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014.